Saturday, August 29, 2015

Doctors have long faced a conundrum in prescribing statins to lower cholesterol and heart attack risk: The drugs are cheap and effective for most people, and large, rigorous clinical trials have found minimal side effects. But as many as 25 percent of those who try them complain of muscle pain. Others stop taking the drugs because, they say, they cause a hazy memory or sleep problems, among other side effects not documented in studies.

Now, with the approval on Thursday of the second in a powerful — and very expensive — new class of cholesterol-lowering drugs, the dilemma confronting doctors just got trickier. Should the people who need to lower their cholesterol, but say they cannot tolerate statins, be prescribed new drugs that cost more than $14,000 a year, potentially adding billions of dollars to the nation's medical bill?

Three months ago, my wife, Chrysta, and I were driving along Melrose Avenue in Los Angeles when she let out a harrowing cry.

I knew exactly what to do: I reached for my iPhone and pressed the bright green "Start" button on the screen and continued to drive as I waited for her to stop wailing.

The app I was using is called Full Term, which kept track of the length and intervals of her contractions. The app was, as my wife and I learned while rushing to the hospital for the birth of our first child, more useful than we could have ever imagined.

I should preface this by saying that before we downloaded the app (a last-minute recommendation from a friend when I texted: "OMG! We're in labor!"), I had scoffed at all these baby and pregnancy tools. After all, people have been having babies without apps since the dawn of humanity. Why do we need them now?

Turns out, I was wrong.

When my wife went into labor, for example, we could have tracked it the old-fashioned way: get a stopwatch, a pen and piece of paper, then jot down the duration of each contraction, and the time in between, and then somehow convey that information to our doctor while my wife endures the most intense pain of her life.

Or, we could open Full Term (a free app, though $1 donations are welcome) and press a green button to start, and a red one to stop. It gives you a detailed graph of the overall length and how far apart the labor pains are, which I could then text to our doctor. (We later discovered that we showed up at the hospital a tad early, by about 10 hours.)

In addition to the "go bag" that you pack for the hospital, you need a "go folder" of smartphone apps.

Pregnancy-related apps are not a niche category. According to a 2013 report by Citrix, a software company that tracks app usage, pregnancy-related apps were more popular than fitness apps. And at the Apple iTunes store, four of the top 10 paid medical apps are currently baby-related, including My Baby's Beat, Baby Connect and Baby Heartbeats.

Two patients, I'll call them Sara and Janine, both learned that they had ductal carcinoma in situ (D.C.I.S.), often referred to as Stage 0 breast cancer. Both underwent lumpectomies in their early 50s. Told that worrisome cells were found, both had another surgery. Then a third surgery was recommended.

Sara decided she would rather live with the risk. Janine had the opposite response. "Let's get this all out," she said.

Each is certain she made the best decision, but can both of them be right?

Each year about 60,000 American women are told that they have D.C.I.S., a cluster of cancer cells currently limited to the milk duct, but which may eventually spread. It used to be rare, but widespread mammographyhas led to the discovery of more of these cancers. The logic of "catching it early" now has a twist: Despite the removal of thousands of D.C.I.S. lesions each year, there hasn't been a drop in the incidence of invasive breast cancers. Some argue D.C.I.S. should not even be called cancer.

Now there's a sense that some women with D.C.I.S. probably derive little benefit from treatment. But while treatment may not be helpful for some, we still don't know enough to confidently say to any individual woman, "Your D.C.I.S. will never progress." We are thus left treating virtually everyone.

Last week a study added to the confusion. The authors used a cancer incidence database to look at the chances of dying or having a recurrence among more than 100,000 women given a diagnosis of and treated for D.C.I.S. The primary finding, and one that can't be overemphasized, is that the chances of dying from D.C.I.S. are quite low, about 3.3 percent at 20 years. Nevertheless, for some groups the risk was more than twice as high.

The most misleading suggestion from the media coverage would be that the study establishes the safety of not getting treatment. It does not.

The study does not compare treatment to no treatment because everyone was treated, as surgery is part of the standard of care. The opposite interpretation would be equally valid: Low mortality rates might instead show that treatment has been working.

As many as 60,000 American women each year are told they have a very early stage of breast cancer — Stage 0, as it is commonly known — a possible precursor to what could be a deadly tumor. And almost every one of the women has either a lumpectomy or a mastectomy, and often a double mastectomy, removing a healthy breast as well.

Yet it now appears that treatment may make no difference in their outcomes. Patients with this condition had close to the same likelihood of dying of breast cancer as women in the general population, and the few who died did so despite treatment, not for lack of it, researchers reported Thursday in JAMA Oncology.

Their conclusions were based on the most extensive collection of data ever analyzed on the condition, known as ductal carcinoma in situ, or D.C.I.S.: 100,000 women followed for 20 years. The findings are likely to fan debate about whether tens of thousands of patients are undergoing unnecessary and sometimes disfiguring treatments for premalignant conditions that are unlikely to develop into life-threatening cancers.